Despite current anti-obesity treatments the number of overweight and obese people is expected to rise to 2.3 billion and 700 million worldwide, respectively in the near future. Given the well understood risks of the development of further conditions associated with obesity, such as for example Type 2 diabetes, and heart disease, these figures effectively represent an economic healthcare time-bomb.
Currently there are many active development programmes looking both for potential treatments for obesity/weight maintenance, including both the search for new pharmaceutical or biopharmaceutical compounds having an impact upon the way in which food is internally processed by an obese subject, as well as the search for greater understanding of the nutritional value of foodstuffs, and particularly how they are digested.
A key part of the early development stages in the development of any new pharmaceutical or biopharmaceutical treatment for obesity it is necessary to assess the potential impact of test compounds on digestion. Whilst it is generally accepted that use of validated ex vivo model systems are of significant value within the development process as a replacement for animal models, both from an ethical and commercial perspective, to date it has not been possible to fully assess the potential impact of test compounds on the digestive system because there is presently no physiologically relevant in vitro model gut system (MGS) capable of simulating the digestive process of the gastrointestinal (GI) tract from the mouth to terminal small intestine. Thus there is a need for reliable, physiologically relevant in vitro model gut system (MGS) capable of simulating the digestive process of the gastrointestinal (GI) tract from the mouth to terminal small intestine. In addition there is a need for a model that can simulate carbohydrate, lipid and protein digestion simultaneously and which thus facilitates the study of whole food digestion, rather individual components.
The Applicant has recognised that in tandem with the need for new effective treatments for obesity, a parallel need exists to identify actives/compounds that positively or negatively influence the digestion of macromolecules, for example to provide improved understanding of the chemical and enzymatic digestion of the macronutrients in foodstuffs, and in particular the digestion of mixed macronutrient systems.
Prior to the present invention it has not been possible to analyse the chemical and enzymatic digestion of a mixed system of the macronutrients, triglycerides, protein and/or carbohydrate in an in vitro MGS cumulative of the mouth, stomach and small intestine.